Description:FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(Section 10 and Rule 13)

1. TITLE OF THE INVENTION:
CUTTING BALLOON
2. APPLICANT:
Meril Life Sciences Pvt. Ltd., an Indian company of the address Survey No. 135/139 Bilakhia House, Muktanand Marg, Chala, Vapi-Gujarat 396191, India.

The following specification particularly describes the invention and the manner in which it is to be performed:

 
FIELD OF INVENTION
[001] The present invention relates to a medical device. More specifically, the present invention relates to a cutting balloon.
BACKGROUND OF INVENTION
[002] Blood vessels carry oxygen and nutrients throughout the body and remove waste from the tissues. However, when the waste deposits on the inner wall of the blood vessels, common vascular problems arise. The waste deposits are referred to as plaque. A plaque is made of cholesterol, fat, calcium, and other substances. Over time, a plaque can narrow or block the arteries, reducing blood flow to the organs and tissues.
[003] Common way to treat such conditions might involve dilating (opening) the blood vessel using a minimally invasive procedure. During the procedure, a thin, flexible tube called a catheter is inserted into a blood vessel, usually in the groin or arm. The catheter is then guided to the blocked or narrowed blood vessel. A balloon (also known as Percutaneous Transluminal Angioplasty (PTA) balloon) is inflated at the end of the catheter to widen the blood vessel and improve blood flow.
[004] However, conventionally available PTA balloons often fail to effectively expand highly calcified or fibrotic lesions thus, often leaving behind uneven residual stenosis, especially in hard lesions. Overinflation of the PTA balloons can cause damage to the walls of the blood vessels, including dissection and/or tears. Moreover, with the conventional PTA balloons, the risk of restenosis remains high due to incomplete plaque modification or vessel injury.
[005] Therefore, in light of the foregoing discussion, there exists a need for a device to overcome the aforementioned drawbacks.
SUMMARY OF INVENTION
[006] The present invention relates to a cutting balloon device including a balloon and support structure. The balloon includes a proximal section, a distal section and a central section. The support structure is coupled at least partially, to the central section of the balloon. The support structure includes a plurality of ribs and a plurality of scoring elements. The plurality of ribs extending at least partially along the length of the central section of the balloon. Each rib includes at least one vertical edge. One scoring element of the plurality of scoring elements is coupled to a vertical edge of one rib of the plurality of ribs and extends at least partially along length of the one rib. Further, the scoring elements subtend a predefined angle with the corresponding ribs, in a deployed state.
[007] The foregoing features and other features as well as the advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
BRIEF DESCRIPTION OF DRAWINGS
[008] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentalities disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[009] Figs. 1a-1b depict a device 100 in a collapsed state and in an expanded state respectively, according to an embodiment of the present disclosure.
[0010] Fig. 2 depicts a balloon 200 on which a support structure 300 of the device 100 is mounted, according to an embodiment of the present disclosure.
[0011] Fig. 3a depicts the support structure 300 of the device 100, according to an embodiment of the present disclosure.
[0012] Fig. 3b depicts the side view of the support structure 300 of the device 100, in an expanded state showing a detailed view of the angle subtended by a scoring element 320 with a rib 310 of the support structure 300, according to an embodiment of the present disclosure.
[0013] Fig. 3c depicts a side perspective view of the support structure 300 of the device 100 in expanded state, according to another embodiment of the present disclosure.
[0014] Figs. 4a-4b depict perspective views of various embodiments of the support structure 300 with the balloon 200, in the expanded state according to different embodiments of the present disclosure.
[0015] Fig. 5a depicts a first attachment 400, according to an embodiment of the present invention.
[0016] Fig. 5b depicts a second attachment 450, according to an embodiment of the present disclosure.
[0017] Fig. 5c depicts an assembly of the device 100, the first attachment 400 and the second attachment 450, according to an embodiment of the present disclosure.
[0018] Figs. 6a-6b depict deployment of the assembly using a catheter 500, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[0019] Prior to describing the invention in detail, definitions of certain words or phrases used throughout this patent document will be defined: the terms "include" and "comprise", as well as derivatives thereof, mean inclusion without limitation; the term "or" is inclusive, meaning and/or; the phrases "coupled with" and "associated therewith", as well as derivatives thereof, may mean to include, be included within, interconnect with, contain, be contained within, connect to or with, couple to or with, be communicable with, cooperate with, interleave, juxtapose, be proximate to, be bound to or with, have a property of, or the like; Definitions of certain words and phrases are provided throughout this patent document, and those of ordinary skill in the art will understand that such definitions apply in many, if not most, instances to prior as well as future uses of such defined words and phrases.
[0020] Reference throughout this specification to “one embodiment,” “an embodiment,” or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in one embodiment,” “in an embodiment,” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment, but mean “one or more but not all embodiments” unless expressly specified otherwise. The terms “including,” “comprising,” “having,” and variations thereof mean “including but not limited to” unless expressly specified otherwise. An enumerated listing of items does not imply that any or all of the items are mutually exclusive and/or mutually inclusive, unless expressly specified otherwise. The terms “a,” “an,” and “the” also refer to “one or more” unless expressly specified otherwise.
[0021] Although the operations of exemplary embodiments of the disclosed method may be described in a particular, sequential order for convenient presentation, it should be understood that the disclosed embodiments can encompass an order of operations other than the particular, sequential order disclosed. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Further, descriptions and disclosures provided in association with one particular embodiment are not limited to that embodiment, and may be applied to any embodiment disclosed herein. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed system, method, and apparatus can be used in combination with other systems, methods, and apparatuses.
[0022] Furthermore, the described features, advantages, and characteristics of the embodiments may be combined in any suitable manner. One skilled in the relevant art will recognize that the embodiments may be practiced without one or more of the specific features or advantages of a particular embodiment. In other instances, additional features and advantages may be recognized in certain embodiments that may not be present in all embodiments. These features and advantages of the embodiments will become more fully apparent from the following description and apportioned claims, or may be learned by the practice of embodiments as set forth hereinafter.
[0023] In accordance with the present disclosure, a cutting balloon device (hereinafter referred as, a device) is disclosed. The device is used in vascular surgeries. The device is used to remove one or more blockages and/or stenosis from a blood vessel, thereby improving the blood flow in the blood vessel. The device is used to treat various diseases such as, without limitation, Peripheral Arterial Disease (PAD), Coronary Artery Bifurcation Lesions, Carotid Artery Interventions, etc.
[0024] The device of the present disclosure includes one or more scoring elements. The scoring elements of the device help in incising one or more blocking elements (for example, without limitation, plaque, calcified deposits, fibrotic tissue, thrombotic clots, etc.) precisely. The one or more precise incisions in the blocking elements by the device, also eliminates the chances of residual stenosis, leading to lower restenosis rates, promoting smoother and more controlled vessel dilation. Further, the device of the present disclosure minimizes vessel trauma due to scoring (or cutting) of the blocking element precisely.
[0025] Referring to the figures, Figs. 1a-1b depict a cutting balloon device 100 (hereinafter a device 100) in a collapsed state and in an expanded state respectively. The device 100 is deployed in a blood vessel, to treat a blockage and/or stenosis. The device 100 includes a balloon 200 and a support structure 300. The support structure 300 is mounted on the balloon 200.
[0026] The balloon 200 (detailed view in Fig. 2) of the device 100, includes a proximal section 200a, a distal section 200b and a central section 200c. The balloon 200 is provided in the hollow interior of the support structure 300. For example, the outer surface of the balloon 200 is coupled to an inner surface of the support structure 300. The balloon 200 may be coupled to the support structure 300 using, without limitation, suturing, adhesive bonding, UV bonding etc. In an embodiment, the balloon 200 is coupled to the support structure 300 using UV bonding. The balloon 200 may be made of any material such as, without limitation, Polyurethane, Pebax, Nylon (Non-Compliant), Silicone, Polyethylene Terephthalate (PET), etc. In an embodiment, the balloon 200 is made of Nylon (Non-Compliant). The balloon 200 is radially collapsible and expandable. Due to this property of the balloon 200, the balloon 200 is used to radially, collapse (shown in Fig. 1a) or expand (shown in Fig. 1b) the support structure 300 of the device 100.
[0027] The support structure 300 has a substantially tubular structure. The support structure 300 is configured to be in one of a radially collapsed state or a radially expanded state. The support structure 300 may be made of any suitable biocompatible and/or shape-memory material such as, without limitation, Nitinol, stainless steel, cobalt-chromium alloy, titanium, or a combination thereof. In an embodiment, the support structure 300 is made of nitinol tube. The support structure 300 is configured to be mounted at least partially on the central section 200c of the balloon 200.
[0028] As shown in an exemplary depiction in Fig. 3a, the support structure 300 includes, one or more ribs 310 and one or more scoring elements 320. The support structure 300 coupled at least partially to the central section 200c of the balloon 200. More specifically, the one or more ribs 310 may extend at least partially along the length of the central section 200c of the balloon 200. For example, the ribs 310 may extend along the entire length of the central section 200c of the balloon 200. Alternately, the ribs 310 may be provided only up to say, 70% of the length of the central section 200c of the balloon 200. The ribs 310 may have a suitable cross-section such as, without limitation, rectangular, circular, elliptical, triangular, hexagonal, etc. In an embodiment, the ribs 310 have a rectangular cross-section. Each rib 310 includes at least one vertical edge. The vertical edge of the rib 310 may be parallel to its length.
[0029] Two consecutive ribs 310 are spaced apart, defining a gap between the two consecutive ribs 310. The gap is introduced to ensure a scoring element 320 can be placed in the gap. In the radially collapsed state of the support structure 300, the gap between the two consecutive ribs 310, is narrow. In the radially expanded state of the support structure 300, the gap between the two consecutive ribs 310, is wide. The gap between the two consecutive ribs 310 may be uniform or non-uniform. In an embodiment, the gap between two consecutive ribs 310 is uniform. The one or more ribs 310 provides structural support to the balloon 200 and enhance the force applied to break the calcified region in the arteries.
[0030] The one or more scoring elements 320 may be coupled to the at least one vertical edge of the rib 310. The one or more scoring elements 320 are extended at least partially along the length of the one or more ribs 310. In an embodiment, a scoring element 320 is provided along the entire length of the vertical edge of the respective rib 310. In another embodiment, the scoring element 320 is provided say, 70% of the length of the vertical edge of the respective rib 310.
[0031] The one or more scoring elements 320 may subtend a predefined angle ‘x’ with the ribs 310, in the deployed or expanded state of the support structure 300 as shown in Fig. 3b. More specifically, the angle ‘x’ is the angle between the plane of the ribs 310 and the scoring elements 320. The angle ‘x’ ranges between 5 degrees to 65 degrees.
[0032] Each scoring element 320 includes a coupled edge and a free edge. The coupled edge is attached to the respective rib 310. The free edge of the scoring element 320 is used to score (or cut) the one or more blocking elements that create blockages in blood vessels. The scoring elements 320 narrow in width from a coupled edge to a free edge. The free edge of the scoring element 320 may be without limitation, a blade, micro-serrated edge, a wire, an abrasive surface, a needle-like tip, etc. In an embodiment, the scoring element 320 is a blade. In an embodiment, the width of the scoring elements 320 reduces from the coupled edge to the free edge.
[0033] Additionally and optionally, as depicted in Fig. 3c, the support structure 300 includes one or more first struts 330, one or more second struts 340, a proximal connector 350a and a distal connector 350b. The one or more first struts 330 is configured to connect the one or more ribs 310 positioned over the proximal section 200a of the balloon 200, to the proximal connector 350a of the support structure 300. More specifically, the first struts 330 connect the proximal end 310a of the ribs 310, to the proximal connector 350a. The one or more first struts 330 may have a suitable cross-section such as, without limitation, rectangular, circular, elliptical, triangular, hexagonal, etc. In an embodiment, the first strut 330 has a rectangular cross-section.
[0034] In an embodiment, the optional one or more second struts 340 is configured to connect the one or more ribs 310 positioned over the distal section 200b of the balloon 200, to the distal connector 350b of the support structure 300. More specifically, the first struts 330 connect the distal end 310b of the ribs 310, to the distal connector 350b. The one or more second struts 340 may have a suitable cross-section such as, without limitation, rectangular, circular, elliptical, triangular, hexagonal, etc. In an embodiment, the second strut 340 has a rectangular cross-section. The first struts 330 and the second struts 340 of the support structure 300 provide controlled expansion capability to the balloon 200.
[0035] Various embodiments of the one or more ribs 310 and the one or more scoring elements 320 are within the scope and teachings of the present disclosure. For example, as depicted in Fig. 1b, each rib 310 is provided with a scoring element 320. In another embodiment as depicted in Fig. 4a, the scoring element 320 is provided on alternate ribs of the one or more ribs 310.
[0036] In accordance with yet another embodiment as depicted in Fig. 4b, the scoring elements 320 extend only up to a partial length of the respective ribs 310. It is to be noted that several other arrangements of the one or more ribs 310 and the one or more scoring elements 320 along with or without one or more first struts 330 and one or more second struts 340 are possible and within the teachings of the present disclosure.
[0037] Though various embodiments depicted in Figs. 4a-4b are shown in the presence of the plurality of first struts 330 and the plurality of second struts 340. It is to be noted, the plurality of first struts 330, the plurality of second struts 340, the proximal connector 350a and the distal connector 350b are optional. Hence, the embodiments covered in Figs. 4a-4b may be considered in the absence of the first struts 330, second struts 340, proximal connector 350a and the distal connector 350b.
[0038] In an embodiment of the device 100 without the optional first struts 330 and optional second struts 340, the connectors 350 are directly coupled to the respective ends of the first struts 330 and second struts 340.
[0039] The one or more ribs 310, the one or more scoring elements 320, the optional one or more first struts 330 and the optional one or more second struts 340 of the support structure 300, may be laser cut from a tube. Alternately, some or all of these may be separate components and thereafter welded, soldered, brazed, etc. together.
[0040] Figs. 5a-5b depict the first attachment 400 and the second attachment 450 to be coupled to the device 100 for deployment. The first attachment 400 is provided at the proximal end 100a of the device 100. The first attachment 400 has a substantially tubular structure. In an embodiment, the first attachment 400 includes a first portion 402, a second portion 404 and a third portion 406 provided therebetween. The first portion 402 is provided proximal to the second portion 404 and the third portion 406. The second portion 404 is provided distal to the third portion 406. The third portion 406 couples the first portion 402 with the second portion 404. In an embodiment, the third portion 406 tapers from a distal end of the first portion 402 to a proximal end of the second portion 404 (in other words, the third portion 406 extends between a distal end of the first portion 402 and a proximal end of the second portion 404).
[0041] The first portion 402 and the second portion 404 include a respective predefined length and a respective predefined diameter. The first portion 402 and the second portion 404 may have the same or different lengths ranging between 1mm and 4mm. In an embodiment, the first portion 402 and the second portion 404 have different lengths. In an exemplary embodiment, the respective predefined lengths of the first portion 402 and the second portion 404 are 2mm and 2.5mm, respectively.
[0042] In an embodiment, the first portion 402 has a varying diameter. In an embodiment, the first portion 402 is narrower than the second portion 404. In an embodiment, the respective diameter of the first portion 402 and the second portion 404 may range between 1mm to 4mm and 1mm to 4mm respectively.
[0043] The first attachment 400 is coupled to a catheter 500 at one end and the support structure 300 at the other end. In an embodiment, the proximal end of the first portion 402 of the first attachment 400 is configured to couple to a catheter 500 (as explained later, in reference to Figs. 6a-6b). In an embodiment, the second portion 404 of the first attachment 400 is configured to couple to the support structure 300. The first attachment 400 may be made of a biocompatible shape setting material, such as, without limitation, Pebax, Nitinol, polyurethane, silicone etc., or a combination thereof. In an embodiment, the first attachment 400 is made of Pebax.
[0044] The second attachment 450 has a tubular structure. The second attachment 450 is provided at the distal end 100b of the device 100. The second attachment 450 includes a proximal end 450a and a distal end 450b. In an embodiment, the second attachment 450 is closed at the distal end 450b. The second attachment 450 is tapered towards the distal end 450b. The second attachment 450 is configured to couple to the support structure 300 (as explained later). The second attachment 450 may be made of a biocompatible shape setting material, such as, without limitation, Nitinol, stainless steel, cobalt-chromium alloy, titanium etc., or a combination thereof. In an embodiment, the second attachment 450 is made of nitinol tube. The first attachment 400 and the second attachment 450 provide controlled inflation and deflation of the device 100.
[0045] Now, the coupling of the first attachment 400, the second attachment 450 and the device 100 is explained further. The first attachment 400 may be coupled to or integrated at the proximal end 100a of the device 100. The first attachment 400 may be coupled to the device 100 using a suitable technique, such as, without limitation, UV (Ultraviolet) bonding, adhesive bonding, thermal bonding, welding etc. In an embodiment, the first attachment 400 is coupled to the device 100 using UV bonding. The second attachment 450 may be coupled to or integrated at the distal end 100b of the device 100. The second attachment 450 may be coupled to the device 100 using a suitable technique, such as, without limitation, UV (Ultraviolet) bonding, adhesive bonding, thermal bonding, welding etc. In an embodiment, the second attachment 450 is coupled to the device 100 using UV bonding.
[0046] Further, an assembly obtained post coupling the first attachment 400, the second attachment 450 and the device 100, is then deployed in the blood vessel at the target site using the catheter 500. Fig. 5c depicts the assembly. Herein, the target site without limitation, includes a blood vessel containing one or more blockages.
[0047] In an embodiment, the assembly is coupled to the catheter 500, at the proximal end 100a (as shown in Fig. 6a). The assembly post coupling with the catheter 500, is introduced in a body vasculature in a collapsed state. In an embodiment, in the collapsed state, the plane of the scoring elements 320 is parallel to the plane of the ribs 310 (as shown in Fig. 5a). The position of the scoring elements 320 in collapsed state provides protection to the underlying balloon 200, from the sharp edges of the scoring elements 320.
[0048] Once the catheter 500 is positioned at the target site, the assembly is uncovered from a catheter sheath. Thereafter, the device 100 of the assembly, is expanded using the catheter 500. In an embodiment, an inflation media is injected into the catheter 500 to inflate the balloon 200. Consequently, the underlying balloon 200 applies a radial outward force on the support structure 300, causing it to expand (as shown in Fig. 6b).
[0049] Simultaneously, as the balloon 200 expands, the scoring elements 320 come in contact with the blockage in the target site of the blood vessel and cuts the same. Once the blockage is removed, the balloon 200 is deflated, consequently resulting in collapse of the device 100.
[0050] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. , Claims:WE CLAIM
1. A cutting balloon device (100) comprising:
a. a balloon (200) having a proximal section (200a), a distal section (200b) and a central section (200c); and
b. a support structure (300) coupled at least partially to the central section (200c) of the balloon (200), the support structure (300) comprising:
i. a plurality of ribs (310) extending at least partially along the length of the central section (200c) of the balloon (200), each rib (310) including at least one vertical edge; and
ii. a plurality of scoring elements (320), one scoring element of the plurality of scoring elements (320) coupled to a vertical edge of one rib of the plurality of ribs (310) and extends at least partially along length of the one rib (310),
wherein the scoring elements (320) subtend a predefined angle with the corresponding ribs (310), in a deployed state.
2. The device (100) as claimed in claim 1 wherein, the support structure (300) includes one or more first struts (330) configured to connect to respective ribs (310), the one or more first struts (330) positioned over the proximal section (200a) of the balloon (200).
3. The device (100) as claimed in claim 1 wherein, the support structure (300) includes one or more second struts (340) configured to connect to respective ribs (310), the one or more second struts (340) positioned over the distal section (200b) of the balloon (200).
4. The device (100) as claimed in claim 1 wherein, the support structure (300) includes a proximal connector (350a) and a distal connector (350b).
5. The device (100) as claimed in claim 1 wherein, the ribs (310) include a rectangular cross-section.
6. The device (100) as claimed in claim 1 wherein, two consecutive ribs (310) of the plurality of ribs (310) are spaced apart, defining a gap between the two consecutive ribs (310).
7. The device (100) as claimed in claim 1 wherein, the scoring elements (320) narrow in width from a coupled edge to a free edge.
8. The device (100) as claimed in claim 8 wherein, the free edge of the scoring element (320) includes one of an abrasive surface, a blade, micro-serrated edge, a wire, or a needle-like tip.
9. The device (100) as claimed in claim 1 wherein, in the collapsed state, the plane of the scoring elements (320) is parallel to the plane of the respective ribs (310).
10. The device (100) as claimed in claim 1 wherein, the predefined angle ranges from 5 degrees to 65 degrees.
11. The device (100) as claimed in claim 1 wherein, vertical edges of alternate ribs (310) are provided with a respective scoring element (320).
12. The device (100) as claimed in claim 1 wherein, the support structure (300) is made from a shape memory material.
13. The device (100) as claimed in claim 1 wherein, the support structure (300) is substantially tubular.